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Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

NCT06705478 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-05-19

No results posted yet for this study

Summary

A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes.

An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.

Conditions

Interventions

DRUG

Pramipexole ER

Tablets self-administered orally

DRUG

Escitalopram

Tablets self-administered orally

Sponsors & Collaborators

  • Cipla Ltd.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • William R Short, MD · University of Pennsylvania

  • Scott Letendre, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-17
Primary Completion
2026-12-02
Completion
2026-12-02
FDA Drug
Yes

Countries

  • United States
  • Botswana
  • Brazil
  • India
  • Kenya
  • Malawi
  • Mexico
  • Peru
  • Philippines
  • South Africa
  • Thailand
  • Uganda
  • Vietnam
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06705478 on ClinicalTrials.gov